Providing software that is able to analyse, compare and measure huge amounts of data clinical trials, with the aim of detecting anomalies: this is what the company CluePoints accomplished. CluePoints is the outcome of the BioWin ‘SMART’ (Statistical Monitoring Applied to Research Trials) project. SMART was approved four years ago by the Walloon Government and was supported by IDDI (International Drug Development Institute), a pioneer in biostatistics. Their software is so successful that it will be used by the FDA!

Damien Tremolet, executive director at IDDI: “IDDI was founded in 1991 by Marc Buyse. IDDI is a company that delivers services to the pharmaceuticals industry, whose mission is to optimise the clinical development of medicines, biologics and biomarkers, using a unique combination of advanced biostatistics and innovative clinical data management technology.

We work for pharmaceutical companies, biotechnology companies and academic groups in Europe and the USA.”

How did you come up with the idea of submitting a project to BioWin?

Tremolet: “We wanted to create new methods to perform clinical research. In 2010, we created a consortium with GSK Vaccines, ULB and UCL, with the aim of developing and marketing statistical software that can detect anomalies, as well as errors, or even fraud, in clinical trials. We needed funding in order to make the project happen, and we thought of BioWin. We submitted our idea and that is how the SMART project started in 2012 with 1.3 million euros funding for a duration of 30 months.

The CEO of the company CluePoints, François Torche, was also involved in the BioWin project and, according to him, the environment at that time was undeniably favourable towards such a project.

François Torche,CEO of CluePoints: “This project owes its existence to the guidance document issued by the FDA (US Food and Drug Administration) in 2011 on that suggested a risk-based approach towards monitoring activities. To this day, in a great number of clinical trials, investigators have to physically go on site every 6 to 8 weeks in order to ensure, among other activities, that the hard copy information has been correctly transcribed onto electronic systems (Source Data Verification). In its guidelines, which were finalised in 2013, the FDA suggests that this approach is inefficient, expensive and any value added is extremely limited. The pharmaceutical industry should, again according to the FDA, adopt a risk-based approach in order to identify on-site visits that should be made. It also advocates using statistical routines in order to detect atypical sites. In reality, these guidelines are based, among other things, on two scientific publications. The first one was published by Marc Buyse in 1999, on fraud detection. The second one, published in 2010, was drafted by the consortium formed by GSK Vaccines, ULB and UCL. During the summer of 2012, the IDDI Board of Directors decided, based on these findings, to create an independent company to marketthe use of this statistical engine that was able to analyse clinical data, i.e. CluePoints.

So what is the situation today with CluePoints, 4 years on?

Torche: “Today, CluePoints can be described as a technology company in which the statistical engine is the heart of the system to service our clients. However, before getting to that point and being able to sell our software, we had to evangelise the industry. From the beginning we have opted for a Data Quality Oversight approach, an evaluation of data quality. This still is an innovative concept today. This approach emerged at the same time as when the FDA guidelines on Risk-Based Monitoring (RBM) were released. CluePoints therefore capitalised on this RBM momentum by making itself known to pharmaceutical companies as their ideal partner to handle this matter. We began with a service-based offering, as we didn’t have software to ‘sell’ at that stage. From 2012 to 2014, we started developing the Software-As-A-Service (SaaS) platform in order to use the SMART Engine. Since 2015 we have been offering software that is capable of analysing, measuring and comparing data from one site with data from all other sites. This represents 400 to 500 variables per patient and millions of items of data over the course of an entire clinical study. We have become the global technology leader in the RBM market and to date there is no equivalent software available.

Your companies have evolved greatly in recent years. What has been the impact in terms of employment?

Tremolet: “With regard to IDDI, both employment and our revenues have more than doubled since setting up in Wallonia in 2006. We set up business in Louvain-la-Neuve with 35 employees and we currently employ 80. In 2016 alone we hired 21 new people: 11 in Belgium and 10 in the USA.

Torche: “We are familiar with the same kind of exponential growth. There were 5 of us at the launch of the company. 4 years later, there are about thirty of us and we keep on growing. We believe that we will hire another ten people in 2017 in Belgium and in the USA. We also anticipate to double our revenues.”

What does 2017 hold in store for you?

Tremolet: “Lots of hard work and triple digit growth! In October 2016, we entered into a Cooperative Research and Development Agreement (CRADA) with the FDA. The FDA is going to use our statistical monitoring platform to find inaccurate and incomplete data in clinical trial submissions. We have worked for more than two years to finalise this agreement. It will allow us not only to improve and continue to upgrade the software, but it will also help us to win over new clients. This definitely marks a turning point in the life of our business, which already counts several global leaders in its client portfolio.”

Torche: “We expect to see continued growth. We have just heard that the ‘TreatBest’ project, led by Diagenode, and in which IDDI is taking part, has recently been selected by the BioWin panel. The other partners are the ULB, , the Jules Bordet Institutethe ULg. This project is currently under evaluation by the Walloon Region. We should therefore have our work cut out in the months to come.